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Dear Jon Tavarez:

The Food and Drug Administration (FDA) has completed evaluation of your firm's corrective actions in response to our Warning Letter dated January 09, 2026, set forth in your correspondence dated January 20, 2026. Based on your representation that Germaphobix has removed all products, references, and content related to any HIV testing (including any at-home HIV tests, STD panels that include HIV, or similar self-collection kits) from your website and all sales channels, including through any third-party partners or affiliates, and will refrain in the future from offering or distributing any diagnostic devices or self-collection kits for serological testing without first obtaining required FDA marketing authorization, it appears that you have addressed the violation(s) contained in this Warning Letter.

Future FDA surveillance and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during an inspection or through other means.

If you have any questions regarding this letter, please contact the Division of Case Management, CBERDCMRecommendations@fda.hhs.gov.

Sincerely,
/S/
Melissa J. Mendoza, JD
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research